BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 1691621 · Received May 17, 2010

    Report

    Report Number
    2939204-2010-00401
    Event Type
    Death
    Date Received
    May 17, 2010
    Date of Event
    December 1, 2005
    Report Date
    December 1, 2005
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: OTHER FOR ANTICIPATED PROCEDURAL COMPLICATION. THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, IT WAS DETERMINED THAT THE DEVICE WAS USED IN ACCORDANCE WITH THE DIRECTION FOR USE. THE USE OF THE COIL CANNOT BE CONFIRMED TO HAVE HAD A CONTRIBUTORY FACTOR TO THE REPORTED PATIENT COMPLICATIONS. HOWEVER, ISCHEMIA, NEUROLOGICAL DEFICITS INCLUDING STROKE AND PATIENT OUTCOME OF DEATH ARE KNOWN RISKS ASSOCIATED WITH ANEURYSM COILING PROCEDURES AND NOTED AS SUCH IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE SUCCESSFUL COIL EMBOLIZATION OF THE ANTERIOR CEREBRAL ARTERY ANEURYSM. IMMEDIATELY AFTER TREATMENT THE SUBJECT WAS IN STABLE CONDITION. ISCHEMIA WAS REPORTED AS A CLINICAL COMPLICATION ASSOCIATED WITH THE PROCEDURE, DATE OF ONSET UNKNOWN. IT WAS REPORTED THAT APPROXIMATELY 70 DAYS POST THE INDEX PROCEDURE, THE PATIENT EXPIRED DUE TO ROSTROCAUDAL DETERIORATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT (SR) COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003497202SR0

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death EXCELSIOR MICROCATHETER (BOSTON SCIENTIFIC)| TWO MATRIX COILS (BOSTON SCIENTIFIC)